| CTRI Number |
CTRI/2023/11/059747 [Registered on: 10/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study between Nidhigdhikadi syrup and Brihati syrup in dry cough |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Nidhigdhikadi syrup and Brihati syrup in Vataja kasa in Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D chandrashekar |
| Designation |
PG scholar |
| Affiliation |
Alvas ayurveda medical College moodabidri |
| Address |
Department of kaumarabrithya alvas ayurveda medical College moodabidri 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9632654234 |
| Fax |
|
| Email |
postbox9632@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Narayan pai |
| Designation |
Associate professor |
| Affiliation |
Alvas ayurveda medical College moodabidri |
| Address |
Alvas ayurveda medical college and hospital moodabidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D chandrashekar |
| Designation |
PG scholar |
| Affiliation |
Alvas ayurveda medical College moodabidri |
| Address |
Department of kaumarabrithya alvas ayurveda medical College moodabidri 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9632654234 |
| Fax |
|
| Email |
postbox9632@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas ayurveda medical college and hospital |
|
|
Primary Sponsor
|
| Name |
D chandrashekar |
| Address |
Department of kaumarabrithya alvas ayurveda medical College moodabidri |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Chandrashekar |
Alvas Ayurveda Medical College And Hospital |
Department of Kaumarabhritya
Dakshina Kannada
KARNATAKA |
9632654234
postbox9632@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional clinical ethics committee Alvas ayurveda medical college, vidyagiri, moodbidri India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J398||Other specified diseases of upperrespiratory tract. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brihati syrup, Reference: Bhava prakasha, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nidhigdhikadi syrup, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender aged between 06 to 14 years.
2.Patient fulfilling diagnostic criteria.
3.Vataja kasa more than 3 days but less than 14 days duration will be selected.
|
|
| ExclusionCriteria |
| Details |
1.Kasa other than Vataja type are excluded.
2.Vataja kasa as Anubandha lakshana & Upadrava(complication) in other systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Check & Assess the Following Parameters
Dry cough
Headache
Excruciating pain in sides of chest & in the chest
Hoarseness of voice
Dryness in throat & mouth |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the below criteria
Number of cough bouts
Absolute eosinophil count |
10 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, parallel group, actively controlled clinical study with comparative standard study- Brihati syrup and interventional drug- Nidhigdhikadi syrup with the dosage of 5ml (Total 15ml per day) before food TID. The study is conducting on patients of kasa belongs to age of 6years to 14years who gives written and verbal by parents for undergoing clinical Study. Study will be conducting in Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodabidri. Interventional period of this study is 10 days assessment will be done on before treatment, 3rd day, 5th day, 7th day and 10th day. |